1. Purpose; statement of intent. The purpose of this section is to require licensure of manufacturers and wholesalers within or outside the State. The intent of the Legislature is that the board may not adopt rules regarding companies without wholesale facilities or manufacturers’ facilities located in this State that are more restrictive than federal law or regulation.

[PL 2007, c. 402, Pt. DD, §28 (AMD).]

Terms Used In Maine Revised Statutes Title 32 Sec. 13758

A. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Manufacturer: means a person engaged in the manufacture of prescription drugs. See Maine Revised Statutes Title 32 Sec. 13702-A
  • Wholesaler: means a person who buys prescription drugs for resale and distribution to persons other than consumers. See Maine Revised Statutes Title 32 Sec. 13702-A
  • 2. Licensure, manufacturers and wholesalers. All manufacturers and wholesalers whose products are distributed in the State in any manner must be licensed by the board.

    [PL 2007, c. 402, Pt. DD, §28 (AMD).]

    3. Licensure, individuals. An individual who is employed by a manufacturer or wholesaler that is licensed under this subchapter need not obtain licensure under this subchapter.

    [PL 2007, c. 402, Pt. DD, §28 (AMD).]

    4. Form. License forms must state: Applicant’s name; address; day phone; 24-hour phone; ownership status; manufacturer or wholesaler designation; Drug Enforcement Agency and Federal Drug Administration numbers; and date executed. License forms must be executed by an owner or officer of the entity, providing printed name and title.

    [PL 2007, c. 402, Pt. DD, §28 (AMD).]

    5. Fees. Each licensee shall pay a fee as set under section 13724.

    [PL 2007, c. 402, Pt. DD, §28 (AMD).]

    6. Violations. It is unlawful for manufacturers or wholesale companies to distribute prescription drugs in this State unless licensed under the provisions of this subchapter or subchapter 5.

    [PL 2007, c. 402, Pt. DD, §28 (AMD).]

    SECTION HISTORY

    PL 1987, c. 710, §5 (NEW). PL 1987, c. 861, §18 (AMD). PL 1989, c. 502, §B75 (AMD). PL 1997, c. 245, §11 (AMD). PL 2005, c. 262, §B15 (AMD). PL 2007, c. 402, Pt. DD, §28 (AMD).